Patient feedback on the treatment of their persistent facial redness

Conditions: Facial Erythema of Rosacea
MedDRA version: 14.1Level: PTClassification code 10039218Term: RosaceaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2012-005686-12-DE

Lead Sponsor: Galderma R&D

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

In order to be eligible for the study, subjects must fulfil all of the following criteria.
1. Male or female subjects age of 18 years or older,
2. A clinical diagnosis of facial rosacea,
3. A PSA score of 4 (severe) at Baseline prior to the study drug application,
4. A Clinician’s Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at Baseline prior to the study drug application,
5. Females of childbearing potential with a negative urine pregnancy test (UPT) at Baseline and must practice an effective method of contraception during the study: oral/systemic (injectable, patch, etc.) contraception (must have been on a stable dose for 3 months prior to study entry), intrauterine device, bilateral tubal ligation, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,
6. Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, or bilateral ovariectomy, are not required to have a UPT at Baseline,
7. Subjects willing and capable of complying with the extent and degree required by the protocol,
8. Subjects understand and sign an Informed Consent Form at Baseline, prior to any investigational procedure being performed.
Rationale:
1-4: In order to select a suitable population for the clinical trial
5-6: Due to limited amount of data on human pregnancy
7: In order to ensure compliance to the clinical trial
8: Only subjects who provided written consent/authorisation are allowed to participate in this clinical trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Any subject who meets one or more of the following criteria will not be eligible for the study.
1. More than 5 facial inflammatory lesions (papules or pustules) of rosacea,
2. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that share clinical features with rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia,
3. Current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anaesthetics, or alpha agonists,
4. Less than 3 months stable dose treatment for inflammatory lesions of rosacea, tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents,
5. Current diagnosis of Raynaud’s syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren’s syndrome, or depression,
6. Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator,
7. Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator’s Brochure),
8. The subject has received, applied or taken the following treatments within the specified time frame prior to the Day 1 visit:
Topical facial treatments or procedures:
-Any dermatologic/surgical procedure on the face: 4 weeks
-Prescription medications that are indicated, wholly or in part, as a treatment for erythema of rosacea: 4 weeks
-Prescription medications for treatment of acne: 4 weeks
-Immunomodulators: 4 weeks
-Corticosteroids: 4 weeks
-Antibiotics other than those intended for the treatment of inflammatory lesions of rosacea: 2 weeks
-OTC medications for treatment of acne: 1 week
-Astringents or abrasives: 2 days
Systemic treatments:
-Isotretinoin: 6 months
-Immunomodulators: 12 weeks
-Prescription medications that are indicated, wholly or in part, as a treatment for erythema of rosacea:
4 weeks
-Prescription medications for treatment of acne: 4 weeks
-Corticosteroids (oral or injectable): 4 weeks
-Phototherapy: 4 weeks
-Antibiotics other than those intended for the treatment of inflammatory lesions of rosacea: 4 weeks
-Prescription anti-inflammatory medications: 2 weeks
-Chronic, daily use of OTC anti-inflammatory medications (e.g. ibuprofen, naproxen) for more than 1 week (does not include low-dose aspirin for cardiac prophylaxis: 1 week
-Niacin =500 mg per day: 1 week
9. Female who is pregnant or lactating,
10. Exposed to excessive ultraviolet (UV) radiation within one week prior to the Day 1 visit,
11. Presence of beard or excessive facial hair on Day 1, which would interfere with the study treatments or study assessments and refusal to remove for duration of the study,
12. Prior treatment with brimonidine tartrate gel,
13. Current treatment with brimonidine tartrate ophthalmic solution,
14. Current treatment with any topical facial formulation containing brimonidine tartrate or oxymetazoline,
15. Subjects unwilling to refrain from use of prohibited medication or excessive exposition to UV